- According to Merck's researchers, omarigliptin has the same efficacy and safety profile as Januvia (sitagliptin), based on the results of a 24-week study of 642 patients with type 2 diabetes.
- Merck is the biggest seller of oral drugs in the $63 billion diabetes market.
- Like Januvia, omarigliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
When Januvia was approved in October 2006, it was the first approved DPP-4 inhibitor and a major game changer. Not only was it associated with less weight gain and hypoglycemia than other drugs, but it also decreased A1C by 0.6% to 1.5% in clinical trials—a major breakthrough considering that target A1C has traditionally been 7% or less.
Then in 2007, metformin was added to sitagliptin, and along came Janumet. The franchise was successful for some time; however, competition increased as the GLP-1 agonists came along, notably Novo Nordisk's Victoza (liraglutide).
Total 2014 sales for Januvia and Janumet were roughly $6 billion, figure that has been relatively flat for a couple of years. On the upside, Januvia has not been associated with heart failure in clinical trials, like some of the other DPP-4 inhibitors, such as AstraZeneca's Onglyza (saxagliptin).
The bottom line here is that Januvia and Janumet have been proven effective, safe, and tolerable. So having a better oral dosing option seems like a sure way to increase sales for Merck, as well as a good way to stand strong against an increasingly competitive market.